Lab Regulatory Compliance
What do live virus samples, transmissible disease samples, toxic chemicals, complex machinery, controlled substances, and critical results have in common?
A whole lot of safety and quality checks! The lab industry is no stranger to inspections and surveyors. Below is a list of regulatory bodies that monitor labs:
- CLIA – Clinical Laboratory Improvement Amendments of 1988. All labs must be certified to accept Medicare or Medicaid payments.
- Within CLIA, 3 federal agencies are responsible for enforcing the regulations – the FDA, CMS, and the CDC. Each has its own set of standards.
- OSHA – Occupational Safety and Health Administration
- TJC – The Joint Commission, a primary hospital and outpatient lab accreditation body.
- EPA – Environmental Protection Agency
- DHHS – Department of Health and Human Services
All that alphabet soup amounts to one of the highest regulated industries in the country! Initial accreditation is not enough, this is an ongoing practice that labs must maintain, with daily records of quality checks and procedures. Annual renewals and ongoing surprise inspections occur. Safety and quality are always top priorities!